Effect of Indacaterol Maleate in Chronic Obstructive Pulmonary Disease (COPD) on Lung Volume and Related Dyspnea

University of Milan

Status and phase: Completed; Phase 4

Conditions: Tachycardia; Dyspnea; Lung Diseases; COPD; Hypoxemia

Treatments: Drug: Placebo; Drug: Indacaterol maleate

Study type: Interventional

Funder types: Other

Identifiers

NCT01377051

654CEC

Details and patient eligibility

About

The purpose of this study is to determine whether indacaterol maleate 300 micrograms (mcg) is effective in the acute treatment of COPD and in particular on reducing lung hyperinflation and dynamic volumes.

Full description

Enrolled patients: COPD of any disease severity in stable conditions. 48 hours of inhalatory drugs wash out.

Evaluation: Plethysmographic test, blood gas analysis, blood pressure, cardiac frequency and Borg scale evaluation in basal condition and after 60 minutes of indacaterol maleate 300 mcg inhalation.

Enrollment: 60 patients

Sex: All

Ages: 50 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Signature of consensus
• COPD diagnosis
• Age from 50 to 85 years old
• history of COPD at least of one year
• respiratory stable conditions at least of one month
• Any basal FEV1 expressed in % of predicted value
• FEV1/ Forced Vital Capacity (FVC) less than 70%
• Former or active smokers with at least a smoking history of 20 pack year

Exclusion criteria

• Pregnancy
• FEV1/FVC more than 70%
• Known deficit of alpha 1 antitrypsin
• Subjects submitted to a Lung Volume Reduction Surgery (LVRS)
• Subjects with known positivity to Human Immunodeficiency Virus (HIV)
• Misuse of alcool or drugs
• Absence of compliance in performing respiratory tests

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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60 participants in 2 patient groups, including a placebo group

Bronchodilator

Active Comparator group

Description:

Indacaterol maleate 300 mcg will be administered by a third independent investigator following a randomization list.

Treatment:

Drug: Indacaterol maleate

Placebo

Placebo Comparator group

Description:

Will be administered with the same device by a third independent investigator

Treatment:

Drug: Placebo